Kornimate/medical-research-clean huggingface dataset:
investigating cardiovascular adverse events related to cancer treatment

Conditions: Toxicity Due to Chemotherapy; Cardiovascular Morbidity; Cancer, Treatment-Related

Summary: cisplatin, anthracyclines, bleomycin and trastuzumab can cause severe cardiovascular or pulmonary toxicity. why some patients are susceptible to extreme toxicity of cancer treatment is largely unknown. unraveling extreme cardiovascular toxic responses in cancer patients may help understand the pathophysiology of cardiovascular toxicity of these agents and help in understanding the more subtle, long-term cardiovascular side effects that affect a larger part of cancer survivors. with induced pluripotent stem cells we will obtain patient-derived cells to recapitulate and mimic and study pathological (cardiovascular) responses and (cardiovascular) toxicity in vitro.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, a subject must meet all of these criteria: 1. any proven cancer treated with curative intent; 2. age ≥ 18 and ≤ 50 years; 3. able to comply with the protocol; 4. signed written informed consent. there are specific inclusion criteria for every subject group: * severe toxicity during 1 to 3 cycles of anthracyclines; * ≥ 3 months after end of cancer treatment which included the maximum tolerable dose of anthracyclines without (severe) toxicity; * severe toxicity within 1 to 6 cycles of trastuzumab; * ≥ 3 months after end of cancer treatment which included a year of trastuzumab without (severe) toxicity. * severe toxicity during 1 to 3 cycles of cisplatin; * ≥ 1 year after end of cancer treatment which included high-dose cisplatin without toxicity; * severe toxicity during 1 to 3 cycles of bleomycin; * ≥ 1 year after end of cancer treatment which included high-dose bleomycin without toxicity. severe toxicity is defined as any of grade 3 - 4 toxicity according to ctcae 4.03. a potential subject who meets any of the following exclusion criteria will be excluded from participation in this study: 1. history of cardiovascular disease prior to start of cancer treatment, as evidenced by any of the following: symptomatic or treated cardiovascular disease prior to start of cancer treatment; lvef \< 55% at any performed muga scan or echocardiography prior to start of cancer treatment; 2. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, or insufficient understanding of the dutch language; 3. any contraindication for skin biopsy, including: extensive skin disorder precluding biopsy of unaffected skin; known allergy to local anaesthetics; use of anticoagulants and inr \> 3; 4. pregnant or lactating female. furthermore, there are specific exclusion criteria for the control groups: 5. history of cardiovascular disease during or after cancer treatment, as evidenced by any of the following: any symptomatic or treated cardiovascular disease; lvef \< 55% at any performed muga scan or echocardiography.

Keywords: bleomycin cisplatin trastuzumab anthracyclines toxicity
short-course preoperative chemoradiotherapy followed by delayed operation for locally advanced rectal cancer

Conditions: Rectal Cancer

Summary: concurrent chemoradiotherapy (crt) * radiotherapy 25 ㏉/5 fractions (start concomitantly at d1) * ↓ ↓ ↓ ↓ ↓ * radical surgery 6 weeks after completion of chemoradiotherapy * ↑ ↑ ↑ ↑ ↑ d1 - - - - - d5 * 5-fluorouracil 400㎎/㎡/day + lv 20㎎/㎡/day iv bolus during the radiotherapy

radiotherapy using tomotherapy is delivered in 5 gy daily fractions for a total of 25 gy in 5 fractions. a bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered concurrently on day 1-5 during radiotherapy. total mesorectal excision is performed within 6±2 weeks. the pathological response of downstaing is the study endpoint.

Eligibility criteria:
inclusion criteria : * pathologically proven diagnosis of adenocarcinoma of the rectum (located within 8㎝ above the anal verge) * locally advanced and curatively resectable tumor(ct3-4 classification) evaluated with magnetic resonance imaging(mri) with or without transrectal ultrasonography(trus) * age ≥18 * performance status(ecog) 0-2 * cbc/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: hemoglobin ≥ 10 g/dl, absolute neutrophil count(anc) ≥ 1,500 cells/㎣, platelets ≥ 100,000cells/㎣ * metabolic panel within 14 days prior to registration on study, with adequate liver and renal function defined as follows: ast and alt ≤ 60 iu/l, bilirubin ≤ 1.5 mg/dl, serum creatinine ≤ 1.5 mg/dl * patient must provide study-specific informed consent prior to study entry exclusion criteria : * any evidence of distant metastases(m1) * prior invasive malignancy (except non-melanomatous skin cancer and uterine cervical cancer in situ) unless disease free to a minimum of 3 years * hereditary rectal cancer; familial adenomatous polyposis(fap), hereditary non-polyposis colorectal cancer(hnpcc), etc. * impending obstruction (except the case with colostomy) * severe, active comorbidity inappropriate to crt as follows; acute bacterial or fungal infection, transmural myocardial infarction within the last 6 months, unstable arrhythmia, angina and/or congestive heart failure, unstable arrhythmia * pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception * unresected synchronous colon carcinoma * clinically unresectable rectal cancer

Keywords: rectal cancer, short-course, chemoradiotherapy
effects of laser acupuncture therapy on paralytic ileus

Conditions: Paralytic Ileus

Summary: ileus occurs from hypomotility of the gastrointestinal tract. causes of paralytic ileus include post-operation, stroke, and bed-ridden for a long time. medicine treatment is less and less effective over time. some study revealed that moxibustion and acupuncture are effective in paralytic ileus. investigators try to find other treatment except of medicine. laser acupuncture is a safe and non-invasive choice. this study is to evaluate effect of laser acupuncture on paralytic ileus.

this study's sample consisted of 94 adult participants who had paralytic ileus. patients experiencing skin disease or wounds, pregnancy, less than 20 years old, and who take immunosuppressants drugs or morphine, mechanical obstruction were excluded. these 94 patients were randomly divided into two groups: a laser acupuncture group and a control group. at the beginning of study, check x-ray(kub), collect serum gastrin, motilin, and pancreatic polypeptide, and record bowel sound per minute, frequent of enema, average amount of stool per day. 47 patients received laser acupuncture therapy three times a week in acupoints rn6, rn4, and rn12. the whole duration of treatment is 8 weeks. the control group patients receive pseudo laser acupuncture. in the end of 4th and 8th week, check x-ray(kub), collect serum gastrin, motilin, and pancreatic polypeptide, and record bowel sound per minute, observe the daily record and then calculate frequent of enema and average amount of stool per day. after the end of treatment, the investigators keep follow up for 4 weeks. the outcome parameters include: 1. kub, 2. the average amount of stool every day, 3. frequency of bowel sound, 4. frequency of enema, (indication of enema: the amount of stool less than 200g within 3 days), 5. the change of serum gastrin, motilin, and pancreatic polypeptide.

Eligibility criteria:
inclusion criteria: * already sign test consent permit. * more than 20-year-old. * doctors diagnosis as paralysis ileus, and kub report was improved as paralysis ileus by radiologists. exclusion criteria: * pregnant. * patients taking immunosuppressive or morphine analgesics. * skin infections. * without test consent permit. * mechanical ileus, mechanical obstruction.

Keywords: lacer acupuncture paralytic ileus
music interventions for dementia and depression in elderly care

Conditions: Dementia; Depression

Summary: this study evaluates the effectiveness of two music-based approaches - group music therapy and recreational choir singing - for reducing depression symptoms in people living with dementia. it also examines mechanisms and heterogeneity of treatment effects.

dementia and depression are highly prevalent and comorbid conditions in older adults and are associated with individual distress, substantial carer burden, and high societal costs. music interventions represent a highly promising type of non-pharmacological interventions for both dementia and depression in older adults. they are widely used, but have yet to be rigorously tested in large trials. the middel trial is the largest trial of music interventions to date, and the first to compare different music-based interventions - group music therapy (gmt), and recreational choir singing (rcs) - alone and in combination across countries. middel is designed as a large, pragmatic, international cluster-randomised controlled trial with a 2x2 factorial design that will compare the effects of gmt, rcs, both, or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. study sites will be located in australia and in five european countries, and a total of 100 care home units will be randomised to one of the four study conditions.

Eligibility criteria:
inclusion criteria: * resident (full-time, 24h/day) at a participating care home; * dementia as indicated by a clinical dementia rating score of 0.5 or more and a mini-mental state examination (mmse) score of 26 or less; * at least mild depressive symptoms, as indicated by a montgomery-åsberg depression rating scale (madrs) score of at least 8; * a clinical diagnosis of dementia according to icd-10 research criteria; * have given written informed consent (may be assent by proxy for those unable to provide consent themselves). exclusion criteria: * diagnosis of schizophrenia or parkinson's disease; * severe hearing-impairment; * in short-term care; * unable to tolerate sitting in a chair for the duration of the sessions.
evaluation of colecalciferol substitution in dialysis patients

Conditions: RENAL INSUFFICIENCY, CHRONIC; Hyperparathyroidism, Secondary

Summary: the purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system


Eligibility criteria:
inclusion criteria: 1. serum 25-oh-vit.d-levels \< 60 ng/ml 2. age \> 18 years 3. dialysis treatment \> 3 months 4. signed written informed consent 5. serum-calcium-levels \< 2,6 mmol/l within the last 4 weeks 6. serum-phosphate-levels \< 7,0 mg/dl within the last 4 weeks 7. ca x p-product \< 75 mg2/dl2 within the last 4 weeks exclusion criteria: 1. serum 25-oh-vit.-d-levels \> 60 ng/ml 2. concommitant participation in another interventional trial 3. psychiatric disorders preventing from valid informed consent 4. hyperphosphatemia (\> 7,0 mg/dl) within the last 4 weeks 5. hypercalcemia (\> 2,6 mmol/l) within the last 4 weeks 6. ca x p-product \> 75 mg2/dl2 within the last 4 weeks 7. pregnancy or lactation 8. known malignancy 9. liver disease, defined as 2-fold upper limit of asat-, or alat-levels 10. pth levels \< 50 pg/ml 11. current clinically relevant infections treated with antibiotic therapy and raised hscrp levels 12. chronic viral infectious diseases (e.g. hiv, hepatitis b or c) 13. immunosuppressant medication 14. known hematologic disorders, other than renal anemia 15. age below 18 years 16. known anaphylactic reaction against the study medication or other ingredients of the study drug preparation 17. renal calculus 18. pseudohypoparathyroidism 19. medication including cardiac glycosides 20. sarkoidosis
artificial intelligence for detecting retinal diseases

Conditions: Artificial Intelligence; Retinal Diseases

Summary: the objective of this study is to apply an artificial intelligence algorithm to diagnose multi retinal diseases from fundus photography. the effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.

the objective of this study is to apply an artificial intelligence algorithm to diagnose referral diabetes retinopathy, referral age-related macular degeneration, referral possible glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal lesions from fundus photography. the effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, area under curve, and f1 score.

Eligibility criteria:
inclusion criteria: * fundus photography around 45° field which covers optic disc and macula * complete identification information exclusion criteria: * insufficient information for diagnosis.
effects of rosiglitazone on renal hemodynamics and proteinuria of type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy

Conditions: Type 2 Diabetes; Overt Diabetic Nephropathy

Summary: objective: to evaluate how rosiglitazone does influence the renal plasma flow, the glomerular filtration rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy. background: diabetic nephropathy is a world wide public health concern of increasing proportions. it has become the most common single cause of end-stage renal disease in the united states and in europe. previous studies have already found agents modifying the renin-angiotensin-system (ace inhibitors and angiotensin receptor blocker) to retard diabetic nephropathy. these agents are likely to exert multiple effects in the kidney. one of them appear to be their known ability to improve endothelial function and to change renal glomerular hemodynamics. in a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2 diabetic patients without end organ damage after treatment with rosiglitazone. in that study, rosiglitazone significantly reduced glomerular hyperfiltration. this was associated with a reduction of urinary albumin excretion. the observed effects are potentially important in the context of renal protection, provided that a similar beneficial effect of rosiglitazone is demonstrable in overt diabetic nephropathy (renal insufficiency, hypertension, proteinuria). hypothesis rosiglitazone decreases proteinuria and improves renal hemodynamic function in patients with chronic renal insufficiency due to overt diabetic nephropathy.


Eligibility criteria:
inclusion criteria: type 2 diabetes mellitus -age between 40 and 75 years -well controlled hba1c (\ 300 mg / 24 hours exclusion criteria: type 1 diabetes -poorly controlled type 2 diabetes (hba1c \> 7.5%) or unstable blood glucose during the day (capillary blood glucose self monitoring) -elevation of alt, ast or ggt more than 2.5 fold the upper normal value -chf (more than grade 1 of nyha) -uncontrolled hypertension -malignant tumorous disorder -hyper- or hypothyroidism -pregnant women -nursing women

Keywords: type 2 diabetes, glomerular filtration rate, renal plasma flow, endothelial dysfunction, proteinuria, diabetic nephropathy
observational trial with enbrel

Conditions: Rheumatoid Arthritis

Summary: the diagnosis, evaluation and treatment of rheumatoid arthritis (ra) continue to undergo rapid change. randomized controlled trials such as the tempo study have demonstrated the efficacy and safety of the combination of etanercept and methotrexate. importantly, the tempo study showed that patients treated with etanercept and methotrexate could reach the newer therapeutic goals of low disease activity and remission, and that the physicians, patients, and payers are no longer prepared to accept the goal of "reduction of symptoms". rct are important and powerful tools in assessing efficacy and safety but have their limitations in terms of generalisability. in order to assess health economics, clinical effectiveness and safety of etanercept, they need to be measured by performing observational studies of unselected patients. this study aims to provide a holistic assessment of patients receiving etanercept in a real world setting. this will include centers that would not normally take part in rct. the study will assess treatment with etanercept with descriptive statistics of the following parameters: health economic, safety, effectiveness. in addition, there was a previous study of similar design, but of only 3 months duration (101354), which will allow comparison with historical data. since previous study, there have been a number of significant changes: introduction of a new formulation for etanercept (enbrel® 50mg · once weekly), definition of early ra has been modified to short disease duration (from 3 months to 1 year).

non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria:
inclusion criteria: * clinical diagnosis of rheumatoid arthritis exclusion criteria: * sepsis or risk for sepsis, * acute infection, * hypersensitivity against etanercept
diet quality and diabetes risk in overweight and obese adults

Conditions: Overweight; Obesity

Summary: the goal of this observational study is to learn about the relationship between diabetes risk with sociodemographic characteristics, lifestyle and diet quality in overweight and obese individuals. the main question it aims to answer is: is there a relationship between diabetes risk and diet quality in overweight and obese individuals? participants who are overweight and obese will answer survey questions about sociodemographic characteristics and lifestyle behaviors. 24 hour dietary recalls will be taken to evaluate diet quality. findrisc questionnaire will be applied to assess diabetes risk.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥25 kg/m² exclusion criteria: * diabetes mellitus * psychiatric disorders * pregnant and lactating

Keywords: diabetes mellitus obesity diet
tailored to you (tty) pilot study

Conditions: Hypertension

Summary: the purpose of this research study is to use a test called impedance cardiography (icg) to provide more information about how to improve the control of blood pressure. participants will be given this test so investigators can get more information about what is going on inside the heart and blood vessels that is contributing to high blood pressure. icg is a lot like an ekg (electrocardiogram) in that it uses electrodes and a computer to make a report. participants will lie down on the exam table and two electrodes go on the right ankle and two electrodes go on the left wrist. the process takes about 5 minutes and is painless and not invasive.


Eligibility criteria:
inclusion criteria: * documented diagnosis of hypertension * most recent office systolic bp average measured using automated office bp (aobp) is ≥140 mmhg systolic or ≥90 mmhg diastolic * currently prescribed at least one bp-lowering medication * under the care of a primary care clinician exclusion criteria: -
long-term safety and efficacy study of adalimumab in pediatric subjects with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.


Eligibility criteria:
inclusion criteria: - subject must have successfully enrolled and completed m11-290 study exclusion criteria: - subject considered by the investigator, for any reason, to be an unsuitable candidate

Keywords: ulcerative colitis
open label trial of incb07839 to determine effect and safety of incb007839 plus trastuzumab in her2 positive metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a single arm, modified dose escalation, open label trial with the objectives of: (1) determining a safe optimal dose of incb007839 in combination with trastuzumab and docetaxel (2) determining clinical efficacy and safety of incb007839 in combination with trastuzumab and docetaxel.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic breast carcinoma that is her2 positive * measurable disease as defined by the recist criteria * life expectancy greater than or equal to 6 months * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * received any anticancer medications in the 28 days prior to enrollment into this study * received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study. * history of deep venous thrombosis within the last year * contraindication to low dose warfarin therapy * clinically significant cardiomyopathy * prior treatment with incb007839 or trastuzumab or lapatinib
targeted busulfan, fludarabine conditioning regimen for hematopoietic stem cell transplantation in chronic granulomatous disease(cgd)

Conditions: Chronic Granulomatous Disease

Summary: in this study the investigators plan to use optimal busulfan dose through pharmacokinetic study in stem cell transplantation of cgd patients.

chronic granulomatous disease is one of the rare congenital immunodeficiency which can be cured by hematopoietic stem cell transplantation. previous myeloablative conditioning regimen has problems related to the severe toxicities, and non-myeloablative conditioning regimen has the risk of graft failure. recently, reduced-intensity myeloablative conditioning regimen with busulfan and fludarabine was used usually in leukemia patients. busulfan is a highly toxic drug with narrow therapeutic window. in this study we plan to use optimal busulfan dose through pharmacokinetic study in stem cell transplantation of cgd patients.

Eligibility criteria:
inclusion criteria: * patients who are diagnosed as cgd. * patients who need hematopoietic stem cell transplantation with busulfan based conditioning regimen. * age: no limit. * performance status: ecog 0-2. * patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. * heart: a shortening fraction \> 30% and ejection fraction \> 45%. * liver: total bilirubin \< 2 × upper limit of normal; alt \< 3 × upper limit of normal. * kidney: creatinine \ 60 ml/min/1.73m2. * patients must lack any active viral infections or active fungal infection. * appropriate donor is available. * patients (or one of parents if patients age \< 20) should sign informed consent.

Keywords: chronic granulomatous disease hematopoietic stem cell transplantation
clinical outcomes with bilateral implantation of odyssey iols

Conditions: Cataract

Summary: this study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery. subjects will be assessed at least 3 months postoperatively at a single visit. clinical evaluations will include administration of the aiolis and osdi questionnaires, as well as measurement of visual acuities at distance, intermediate, and near.


Eligibility criteria:
inclusion criteria: • patients aged 50 years and older who underwent bilateral cataract surgery with odyssey iol implantation. exclusion criteria: * significant ocular comorbidities (e.g., macular degeneration, glaucoma). * \< 2 weeks post yag capsulotomy. * best corrected distance visual acuity worse than 20/25.